A Phase 4 Clinical Study of Brodalumab

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04183881

Collaborator

(none)

138

Enrollment

Location

Arm

12.6

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study [4827-005 (post market)] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris Psoriatic Arthritis Pustular; Psoriasis, Palmaris Et Plantaris Psoriatic Erythroderma	Drug: Brodalumab 210mg SC	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

Actual Study Start Date :

Jul 4, 2016

Actual Primary Completion Date :

Jan 10, 2017

Actual Study Completion Date :

Jul 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brodalumab 210mg SC Brodalumab 210mg subcutaneous injection	Drug: Brodalumab 210mg SC 210 mg, subcutaneous dosing, every 2 weeks

Arm

Intervention/Treatment

Experimental: Brodalumab 210mg SC

Brodalumab 210mg subcutaneous injection

Drug: Brodalumab 210mg SC

210 mg, subcutaneous dosing, every 2 weeks

Outcome Measures

Primary Outcome Measures

Incidence and types of adverse events and adverse reactions [28 weeks]
Anti-KHK4827 antibody [28 weeks]

Secondary Outcome Measures

Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study. [28 weeks]
Percent improvement in PASI [28 weeks]
PASI 50, 75, 90, and 100 [28 weeks]
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)" [28 weeks]
sPGA of "0 (clear)" [28 weeks]
Change in body surface area involvement (BSA) of lesion [28 weeks]
Clinical Global Impression (CGI) [28 weeks]
American College of Rheumatology (ACR) 20 [28 weeks]
Pustular symptom score [28 weeks]
This score indicate the severity of generalized pustular psoriasis (GPP). The severity of GPP (0:none-3:severe) is classified as mild(1), moderateor(2) severe(3) based on a total score after rating skin symptoms (erythema, pustules and edema) and systemic inflammation accom-panied by certain laboratory findings (fever, white blood cellcount, and serum CRP and albumin levels).
Serum KHK4827 concentration [28 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has voluntarily signed the written informed consent form to participate in this study
Subject has completed the study 4827-005 (phase 3)

Exclusion Criteria:

Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Jikei University Scoole of Medicine	Tokyo		Japan

Sponsors and Collaborators

Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04183881

Other Study ID Numbers:

4827-005 (post market)

First Posted:

Dec 3, 2019

Last Update Posted:

Dec 9, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Psoriatic

Psoriasis

Dermatitis, Exfoliative

Brodalumab

Study Results

No Results Posted as of Dec 9, 2019